Axis-Shield Liquid Stable — Class II medical device recall Z-0743-2020
Ongoing recall by Axis-Shield Diagnostics, Ltd., reported 2020-01-01, distributed nationwide. There is a potential performance issue as detected by an under-recovery of sample results during routine testi
| Recall number | Z-0743-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Axis-Shield Diagnostics, Ltd., Dundee, United Kingdom |
| Recall initiated | 2019-09-16 |
| Classified | 2019-12-26 |
| Reported by FDA | 2020-01-01 |
| Distributed | Nationwide (US) |
| Quantity | 740 total |
| UPC / GTIN / UDI-DI | 05055845400169 |
| Lot numbers | 902924526 |
| Model numbers | FHRWR100 |
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Reason for recall
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0743-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.